RecruitingPhase 2NCT07288216

Transition to KPL-387 Monotherapy Dosing & Administration Study

A Phase 2 Posology Study With Long-Term Extension in Participants With Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy From Standard Therapies

Sponsor

Kiniksa Pharmaceuticals International, plc

Enrollment

80 participants

Start Date

Jan 31, 2026

Study Type

INTERVENTIONAL

Conditions

Pericarditis Heart Diseases Recurrent Pericarditis

Summary

The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)
Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence
Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).

Exclusion Criteria12

Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies
Has had a pericarditis recurrence in the last 3 months prior to Baseline
Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study.
Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
Has a history of immunodeficiency.
Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (\> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.